{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T02:40:12Z","timestamp":1787020812427,"version":"build-2736575974"},"reference-count":46,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T00:00:00Z","timestamp":1748563200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T00:00:00Z","timestamp":1748563200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Alexion Pharmaceuticals, Inc. AstraZeneca Rare Disease"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Cardiac procedures, particularly those requiring cardiopulmonary bypass (CPB), are associated with the development of cardiac surgery-associated acute kidney injury (CSA-AKI). Development of CSA-AKI occurs as a result of inflammation, uncontrolled complement activation, and kidney cell damage. In patients with preoperative renal impairment, such as those with chronic kidney disease (CKD), there is an increased risk of both CSA-AKI and poorer clinical outcomes. Currently, there are limited effective, targeted pharmacological interventions for the prevention or treatment of CSA-AKI, although emerging therapies are being investigated, particularly in patients with existing CKD. The ARTEMIS (R\n                      <jats:italic>A<\/jats:italic>\n                      vulizumab to P\n                      <jats:italic>R<\/jats:italic>\n                      otect Pa\n                      <jats:italic>T<\/jats:italic>\n                      ients with Chronic Kidney Dis\n                      <jats:italic>E<\/jats:italic>\n                      ase fro\n                      <jats:italic>M<\/jats:italic>\n                      CSA-AK\n                      <jats:italic>I<\/jats:italic>\n                      and\n                      <jats:italic>S<\/jats:italic>\n                      ubsequent Major Adverse Kidney Events) trial will assess the efficacy and safety of ravulizumab (a complement C5 inhibitor) in reducing the risk of major adverse kidney events (MAKE) in patients with preoperative CKD undergoing non-emergent cardiac surgery with CPB.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This trial is currently recruiting patients with CKD who have planned cardiac surgery requiring CPB including coronary artery bypass grafting, valve replacement or repair, or combined procedures. This is a phase 3, randomized, double-blind, placebo-controlled, global study assessing the efficacy and safety of a single preoperative dose of ravulizumab. These outcomes will be assessed using the occurrence of MAKE and its components, as well as the occurrence and severity of CSA-AKI throughout the study period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>Complement activation is known to occur during and after cardiac procedures as a result of CPB and ischemia\u2013reperfusion injury, leading to a cycle of cell damage and death. Therefore, it is hypothesized that preoperative administration of ravulizumab will provide immediate and complete complement inhibition, which will be sustained throughout the surgical period, preventing the uncontrolled complement activation associated with the development of CSA-AKI, thus minimizing poor outcomes for patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT05746559. Registered on February 27, 2023.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-025-08895-7","type":"journal-article","created":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T07:29:39Z","timestamp":1748590179000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["A phase 3 study of ravulizumab to protect patients with chronic kidney disease from cardiac surgery-associated acute kidney injury and major adverse kidney events (ARTEMIS)"],"prefix":"10.1186","volume":"26","author":[{"given":"Marlies","family":"Ostermann","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David C.","family":"Corteville","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kent","family":"Doi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jay L.","family":"Koyner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andre","family":"Lamy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerry","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine M.","family":"Solinsky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela D.","family":"Winterberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William T.","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravindra L.","family":"Mehta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick T.","family":"Murray","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew D.","family":"Shaw","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Zarbock","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel T.","family":"Engelman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,5,30]]},"reference":[{"issue":"2","key":"8895_CR1","doi-asserted-by":"publisher","first-page":"275","DOI":"10.1053\/j.ajkd.2014.08.024","volume":"65","author":"I Koulouridis","year":"2015","unstructured":"Koulouridis I, Price LL, Madias NE, Jaber BL. Hospital-acquired acute kidney injury and hospital readmission: a cohort study. Am J Kidney Dis. 2015;65(2):275\u201382.","journal-title":"Am J Kidney Dis"},{"issue":"24","key":"8895_CR2","doi-asserted-by":"publisher","first-page":"5746","DOI":"10.3390\/jcm10245746","volume":"10","author":"A Schurle","year":"2021","unstructured":"Schurle A, Koyner JL. CSA-AKI: incidence, epidemiology, clinical outcomes, and economic impact. J Clin Med. 2021;10(24):5746.","journal-title":"J Clin Med"},{"issue":"5","key":"8895_CR3","doi-asserted-by":"publisher","first-page":"844","DOI":"10.2215\/CJN.12791211","volume":"7","author":"PM Palevsky","year":"2012","unstructured":"Palevsky PM, Molitoris BA, Okusa MD, Levin A, Waikar SS, Wald R, et al. Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology. Clin J Am Soc Nephrol. 2012;7(5):844\u201350.","journal-title":"Clin J Am Soc Nephrol"},{"issue":"1\u20134","key":"8895_CR4","doi-asserted-by":"publisher","first-page":"89","DOI":"10.1159\/000363725","volume":"127","author":"FTT Billings","year":"2014","unstructured":"Billings FTT, Shaw AD. Clinical trial endpoints in acute kidney injury. Nephron Clin Pract. 2014;127(1\u20134):89\u201393.","journal-title":"Nephron Clin Pract"},{"issue":"7","key":"8895_CR5","doi-asserted-by":"publisher","first-page":"559","DOI":"10.3949\/ccjm.85a.17009","volume":"85","author":"K Sharma","year":"2018","unstructured":"Sharma K, Slawski B. Renal disease and the surgical patient: minimizing the impact. Cleve Clin J Med. 2018;85(7):559\u201367.","journal-title":"Cleve Clin J Med"},{"issue":"12","key":"8895_CR6","doi-asserted-by":"publisher","first-page":"1441","DOI":"10.1007\/s00134-023-07169-7","volume":"49","author":"A Zarbock","year":"2023","unstructured":"Zarbock A, Weiss R, Albert F, Rutledge K, Kellum JA, Bellomo R, et al. Epidemiology of surgery associated acute kidney injury (EPIS-AKI): a prospective international observational multi-center clinical study. Intensive Care Med. 2023;49(12):1441\u201355.","journal-title":"Intensive Care Med"},{"issue":"2","key":"8895_CR7","doi-asserted-by":"publisher","first-page":"166","DOI":"10.1159\/000526120","volume":"52","author":"D Zhang","year":"2023","unstructured":"Zhang D, Teng J, Luo Z, Ding X, Jiang W. Risk factors and prognosis of acute kidney injury after cardiac surgery in patients with chronic kidney disease. Blood Purif. 2023;52(2):166\u201373.","journal-title":"Blood Purif"},{"issue":"1","key":"8895_CR8","doi-asserted-by":"publisher","first-page":"32","DOI":"10.1093\/ejcts\/ezu378","volume":"48","author":"HT Tie","year":"2015","unstructured":"Tie HT, Luo MZ, Lin D, Zhang M, Wan JY, Wu QC. Erythropoietin administration for prevention of cardiac surgery-associated acute kidney injury: a meta-analysis of randomized controlled trials. Eur J Cardiothorac Surg. 2015;48(1):32\u20139.","journal-title":"Eur J Cardiothorac Surg"},{"issue":"14","key":"8895_CR9","doi-asserted-by":"publisher","first-page":"1133","DOI":"10.1161\/CIRCULATIONAHA.120.053029","volume":"144","author":"M Thielmann","year":"2021","unstructured":"Thielmann M, Corteville D, Szabo G, Swaminathan M, Lamy A, Lehner LJ, et al. Teprasiran, a small interfering RNA, for the prevention of acute kidney injury in high-risk patients undergoing cardiac surgery: a randomized clinical study. Circulation. 2021;144(14):1133\u201344.","journal-title":"Circulation"},{"issue":"4","key":"8895_CR10","doi-asserted-by":"publisher","first-page":"259","DOI":"10.5414\/CN111514","volume":"103","author":"Z Chen","year":"2025","unstructured":"Chen Z, Liu K, Liu X, Wu B, Huang Z, Xing C, et al. Preoperative dapagliflozin use and cardiac surgery-associated acute kidney injury: a single-center retrospective cohort study. Clin Nephrol. 2025;103(4):259\u201367.","journal-title":"Clin Nephrol"},{"key":"8895_CR11","doi-asserted-by":"crossref","unstructured":"Landoni G, Monaco F, Ti LK, Baiardo Redaelli M, Bradic N, Comis M, et al. A randomized trial of intravenous amino acids for kidney protection. N Engl J Med. 2024;391(8):687\u201398.","DOI":"10.1056\/NEJMoa2403769"},{"issue":"5","key":"8895_CR12","doi-asserted-by":"publisher","first-page":"818","DOI":"10.1097\/ALN.0000000000005336","volume":"142","author":"M Baiardo Redaelli","year":"2025","unstructured":"Baiardo Redaelli M, Monaco F, Bradic N, Scandroglio AM, Ti LK, Belletti A, et al. Amino acid infusion for kidney protection in cardiac surgery patients with chronic kidney disease: a secondary analysis of the PROTECTION trial. Anesthesiology. 2025;142(5):818\u201328.","journal-title":"Anesthesiology"},{"issue":"2","key":"8895_CR13","doi-asserted-by":"publisher","first-page":"ezae354","DOI":"10.1093\/ejcts\/ezae354","volume":"67","author":"A Wahba","year":"2025","unstructured":"Wahba A, Kunst G, De Somer F, Agerup Kildahl H, Milne B, Kjellberg G, et al. 2024 EACTS\/EACTAIC\/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardio-Thoracic Surg. 2025;67(2):ezae354.","journal-title":"Eur J Cardio-Thoracic Surg"},{"key":"8895_CR14","doi-asserted-by":"publisher","unstructured":"Palevsky PM. Kidney PROTECTION after cardiac surgery with intravenous amino acid infusion. Clin J Am Soc Nephrol. 2025. https:\/\/doi.org\/10.2215\/CJN.0000000678. Epub ahead of print. PMID: 39918884.","DOI":"10.2215\/CJN.0000000678"},{"issue":"8","key":"8895_CR15","doi-asserted-by":"publisher","first-page":"sfae229","DOI":"10.1093\/ckj\/sfae229","volume":"17","author":"A Coca","year":"2024","unstructured":"Coca A, Bustamante-Munguira E, Fidalgo V, Fern\u00e1ndez M, Abad C, Franco M, et al. EValuating the effect of periopeRaTIve empaGliflOzin on cardiac surgery associated acute kidney injury: rationale and design of the VERTIGO study. Clin Kidney J. 2024;17(8):sfae229.","journal-title":"Clin Kidney J"},{"issue":"2","key":"8895_CR16","doi-asserted-by":"publisher","first-page":"453","DOI":"10.1053\/j.jvca.2024.10.012","volume":"39","author":"J Miralles Bag\u00e1n","year":"2025","unstructured":"Miralles Bag\u00e1n J, Parrilla Quiles L, Paniagua Iglesias P, Betbes\u00e9 Roig AJ, Sabat\u00e9 Tenas S, P\u00e9rez Garc\u00eda S, et al. The Potential role of albumin in reducing cardiac surgery-associated acute kidney injury: a randomized controlled trial. J Cardiothorac Vasc Anesth. 2025;39(2):453\u201360.","journal-title":"J Cardiothorac Vasc Anesth"},{"key":"8895_CR17","doi-asserted-by":"crossref","unstructured":"Kamla CE, Meersch-Dini M, Palma LMP. Kidney injury following cardiac surgery: a review of our current understanding. Am J Cardiovasc Drugs. 2025;25(3):337\u201348.","DOI":"10.1007\/s40256-024-00715-8"},{"issue":"4","key":"8895_CR18","doi-asserted-by":"publisher","first-page":"189","DOI":"10.1038\/nrneph.2011.16","volume":"7","author":"AA Sharfuddin","year":"2011","unstructured":"Sharfuddin AA, Molitoris BA. Pathophysiology of ischemic acute kidney injury. Nat Rev Nephrol. 2011;7(4):189\u2013200.","journal-title":"Nat Rev Nephrol"},{"issue":"4","key":"8895_CR19","doi-asserted-by":"publisher","first-page":"257","DOI":"10.1051\/ject\/200840257","volume":"40","author":"L Vercaemst","year":"2008","unstructured":"Vercaemst L. Hemolysis in cardiac surgery patients undergoing cardiopulmonary bypass: a review in search of a treatment algorithm. J Extra Corpor Technol. 2008;40(4):257\u201367.","journal-title":"J Extra Corpor Technol"},{"issue":"1","key":"8895_CR20","doi-asserted-by":"publisher","first-page":"291","DOI":"10.1186\/s13019-023-02406-y","volume":"18","author":"YP Bhirowo","year":"2023","unstructured":"Bhirowo YP, Raksawardana YK, Setianto BY, Sudadi S, Tandean TN, Zaharo AF, et al. Hemolysis and cardiopulmonary bypass: meta-analysis and systematic review of contributing factors. J Cardiothorac Surg. 2023;18(1):291.","journal-title":"J Cardiothorac Surg"},{"key":"8895_CR21","doi-asserted-by":"crossref","unstructured":"Billings FTt, Ball SK, Roberts LJ, 2nd, Pretorius M. Postoperative acute kidney injury is associated with hemoglobinemia and an enhanced oxidative stress response. Free Radic Biol Med. 2011;50(11):1480\u20137.","DOI":"10.1016\/j.freeradbiomed.2011.02.011"},{"issue":"6","key":"8895_CR22","doi-asserted-by":"publisher","first-page":"543","DOI":"10.1016\/j.semnephrol.2013.08.005","volume":"33","author":"JW McCullough","year":"2013","unstructured":"McCullough JW, Renner B, Thurman JM. The role of the complement system in acute kidney injury. Semin Nephrol. 2013;33(6):543\u201356.","journal-title":"Semin Nephrol"},{"key":"8895_CR23","doi-asserted-by":"publisher","first-page":"262","DOI":"10.3389\/fimmu.2015.00262","volume":"6","author":"NS Merle","year":"2015","unstructured":"Merle NS, Church SE, Fremeaux-Bacchi V, Roumenina LT. Complement system part I - molecular mechanisms of activation and regulation. Front Immunol. 2015;6:262.","journal-title":"Front Immunol"},{"key":"8895_CR24","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1186\/1755-1536-7-16","volume":"7","author":"JS Danobeitia","year":"2014","unstructured":"Danobeitia JS, Djamali A, Fernandez LA. The role of complement in the pathogenesis of renal ischemia-reperfusion injury and fibrosis. Fibrogenesis Tissue Repair. 2014;7:16.","journal-title":"Fibrogenesis Tissue Repair"},{"issue":"4","key":"8895_CR25","doi-asserted-by":"publisher","first-page":"427","DOI":"10.23876\/j.krcp.19.062","volume":"38","author":"SJ Han","year":"2019","unstructured":"Han SJ, Lee HT. Mechanisms and therapeutic targets of ischemic acute kidney injury. Kidney Res Clin Pract. 2019;38(4):427\u201340.","journal-title":"Kidney Res Clin Pract"},{"issue":"5","key":"8895_CR26","doi-asserted-by":"publisher","first-page":"EVIDoa2100066","DOI":"10.1056\/EVIDoa2100066","volume":"1","author":"T Vu","year":"2022","unstructured":"Vu T, Meisel A, Mantegazza R, Annane D, Katsuno M, Aguzzi R, et al. Terminal complement inhibitor ravulizumab in generalized myasthenia gravis. NEJM Evid. 2022;1(5):EVIDoa2100066.","journal-title":"NEJM Evid"},{"key":"8895_CR27","doi-asserted-by":"crossref","unstructured":"Peffault de Latour R, Brodsky RA, Ortiz S, Risitano AM, Jang JH, Hillmen P, et al. Pharmacokinetic and pharmacodynamic effects of ravulizumab and eculizumab on complement component 5 in adults with paroxysmal nocturnal haemoglobinuria: results of two phase 3 randomised, multicentre studies. Br J Haematol. 2020;191(3):476\u201385.","DOI":"10.1111\/bjh.16711"},{"key":"8895_CR28","doi-asserted-by":"crossref","unstructured":"Lee JW, Sicre de Fontbrune F, Wong Lee Lee L, Pessoa V, Gualandro S, Fureder W, et al. Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: the 301 study. Blood. 2019;133(6):530\u20139.","DOI":"10.1182\/blood-2018-09-876136"},{"issue":"6","key":"8895_CR29","doi-asserted-by":"publisher","first-page":"1287","DOI":"10.1016\/j.kint.2020.01.035","volume":"97","author":"E Rondeau","year":"2020","unstructured":"Rondeau E, Scully M, Ariceta G, Barbour T, Cataland S, Heyne N, et al. The long-acting C5 inhibitor, Ravulizumab, is effective and safe in adult patients with atypical hemolytic uremic syndrome naive to complement inhibitor treatment. Kidney Int. 2020;97(6):1287\u201396.","journal-title":"Kidney Int"},{"issue":"3","key":"8895_CR30","doi-asserted-by":"publisher","first-page":"205","DOI":"10.1111\/ejh.13783","volume":"109","author":"AG Kulasekararaj","year":"2022","unstructured":"Kulasekararaj AG, Griffin M, Langemeijer S, Usuki K, Kulagin A, Ogawa M, et al. Long-term safety and efficacy of ravulizumab in patients with paroxysmal nocturnal hemoglobinuria: 2-year results from two pivotal phase 3 studies. Eur J Haematol. 2022;109(3):205\u201314.","journal-title":"Eur J Haematol"},{"issue":"1","key":"8895_CR31","doi-asserted-by":"publisher","first-page":"89","DOI":"10.1016\/j.jtcvs.2010.08.035","volume":"142","author":"PK Smith","year":"2011","unstructured":"Smith PK, Shernan SK, Chen JC, Carrier M, Verrier ED, Adams PX, et al. Effects of C5 complement inhibitor pexelizumab on outcome in high-risk coronary artery bypass grafting: combined results from the PRIMO-CABG I and II trials. J Thorac Cardiovasc Surg. 2011;142(1):89\u201398.","journal-title":"J Thorac Cardiovasc Surg"},{"issue":"3","key":"8895_CR32","doi-asserted-by":"publisher","first-page":"781","DOI":"10.1016\/j.athoracsur.2006.02.024","volume":"82","author":"PK Smith","year":"2006","unstructured":"Smith PK, Carrier M, Chen JC, Haverich A, Levy JH, Menasch\u00e9 P, et al. Effect of pexelizumab in coronary artery bypass graft surgery with extended aortic cross-clamp time. Ann Thorac Surg. 2006;82(3):781\u20138 discussion 8\u20139.","journal-title":"Ann Thorac Surg"},{"issue":"2","key":"8895_CR33","doi-asserted-by":"publisher","first-page":"486","DOI":"10.1016\/j.athoracsur.2005.12.035","volume":"82","author":"A Haverich","year":"2006","unstructured":"Haverich A, Shernan SK, Levy JH, Chen JC, Carrier M, Taylor KM, et al. Pexelizumab reduces death and myocardial infarction in higher risk cardiac surgical patients. Ann Thorac Surg. 2006;82(2):486\u201392.","journal-title":"Ann Thorac Surg"},{"issue":"3","key":"8895_CR34","doi-asserted-by":"publisher","first-page":"434","DOI":"10.1016\/j.ekir.2018.11.010","volume":"4","author":"AM Siedlecki","year":"2019","unstructured":"Siedlecki AM, Isbel N, Vande Walle J, James Eggleston J, Cohen DJ, Licht C, et al. Eculizumab use for kidney transplantation in patients with a diagnosis of atypical hemolytic uremic syndrome. Kidney Int Rep. 2019;4(3):434\u201346.","journal-title":"Kidney Int Rep"},{"key":"8895_CR35","doi-asserted-by":"publisher","first-page":"e7586","DOI":"10.1136\/bmj.e7586","volume":"346","author":"AW Chan","year":"2013","unstructured":"Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.","journal-title":"BMJ"},{"issue":"5","key":"8895_CR36","doi-asserted-by":"publisher","first-page":"1411","DOI":"10.1016\/j.athoracsur.2018.03.002","volume":"105","author":"DM Shahian","year":"2018","unstructured":"Shahian DM, Jacobs JP, Badhwar V, Kurlansky PA, Furnary AP, Cleveland JC Jr, et al. The Society of Thoracic Surgeons 2018 adult cardiac surgery risk models: part 1-background, design considerations, and model development. Ann Thorac Surg. 2018;105(5):1411\u20138.","journal-title":"Ann Thorac Surg"},{"issue":"5","key":"8895_CR37","doi-asserted-by":"crossref","first-page":"1419","DOI":"10.1016\/j.athoracsur.2018.03.003","volume":"105","author":"SM O'Brien","year":"2018","unstructured":"O\u2019Brien SM, Feng L, He X, Xian Y, Jacobs JP, Badhwar V, et al. The Society of Thoracic Surgeons 2018 adult cardiac surgery risk models: part 2-statistical methods and results. Ann Thorac Surg. 2018;105(5):1419\u201328.","journal-title":"Ann Thorac Surg"},{"issue":"1","key":"8895_CR38","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1016\/j.nut.2011.02.007","volume":"28","author":"LM van Venrooij","year":"2012","unstructured":"van Venrooij LM, Verberne HJ, de Vos R, Borgmeijer-Hoelen MM, van Leeuwen PA, de Mol BA. Postoperative loss of skeletal muscle mass, complications and quality of life in patients undergoing cardiac surgery. Nutrition. 2012;28(1):40\u20135.","journal-title":"Nutrition"},{"issue":"9\u201310","key":"8895_CR39","doi-asserted-by":"publisher","first-page":"775","DOI":"10.1159\/000533173","volume":"52","author":"S De Rosa","year":"2023","unstructured":"De Rosa S, Greco M, Rauseo M, Annetta MG. The good, the bad, and the serum creatinine: exploring the effect of muscle mass and nutrition. Blood Purif. 2023;52(9\u201310):775\u201385.","journal-title":"Blood Purif"},{"key":"8895_CR40","doi-asserted-by":"crossref","unstructured":"Maeda A, Inokuchi R, Bellomo R, Doi K. Heterogeneity in the definition of major adverse kidney events: a scoping review. Intensive Care Med. 2024;50(7):1049\u201363.","DOI":"10.1007\/s00134-024-07480-x"},{"issue":"9","key":"8895_CR41","doi-asserted-by":"publisher","first-page":"497","DOI":"10.1056\/NEJM198102263040901","volume":"304","author":"DE Chenoweth","year":"1981","unstructured":"Chenoweth DE, Cooper SW, Hugli TE, Stewart RW, Blackstone EH, Kirklin JW. Complement activation during cardiopulmonary bypass: evidence for generation of C3a and C5a anaphylatoxins. N Engl J Med. 1981;304(9):497\u2013503.","journal-title":"N Engl J Med"},{"issue":"10","key":"8895_CR42","doi-asserted-by":"publisher","first-page":"3542","DOI":"10.1161\/01.CIR.96.10.3542","volume":"96","author":"P Bruins","year":"1997","unstructured":"Bruins P, te Velthuis H, Yazdanbakhsh AP, Jansen PG, van Hardevelt FW, de Beaumont EM, et al. Activation of the complement system during and after cardiopulmonary bypass surgery: postsurgery activation involves C-reactive protein and is associated with postoperative arrhythmia. Circulation. 1997;96(10):3542\u20138.","journal-title":"Circulation"},{"issue":"1","key":"8895_CR43","doi-asserted-by":"publisher","first-page":"86","DOI":"10.1002\/jha2.371","volume":"3","author":"R Kefalogianni","year":"2022","unstructured":"Kefalogianni R, Kamani F, Gaspar M, Aw TC, Donovan J, Laffan M, et al. Complement activation during cardiopulmonary bypass and association with clinical outcomes. EJHaem. 2022;3(1):86\u201396.","journal-title":"EJHaem"},{"issue":"27","key":"8895_CR44","doi-asserted-by":"publisher","first-page":"734","DOI":"10.15585\/mmwr.mm6627e1","volume":"66","author":"LA McNamara","year":"2017","unstructured":"McNamara LA, Topaz N, Wang X, Hariri S, Fox L, MacNeil JR. High risk for invasive meningococcal disease among patients receiving eculizumab (Soliris) despite receipt of meningococcal vaccine. MMWR Morb Mortal Wkly Rep. 2017;66(27):734\u20137.","journal-title":"MMWR Morb Mortal Wkly Rep"},{"issue":"2","key":"8895_CR45","doi-asserted-by":"publisher","first-page":"297","DOI":"10.1111\/bjh.15790","volume":"185","author":"G Socie","year":"2019","unstructured":"Socie G, Caby-Tosi MP, Marantz JL, Cole A, Bedrosian CL, Gasteyger C, et al. Eculizumab in paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome: 10-year pharmacovigilance analysis. Br J Haematol. 2019;185(2):297\u2013310.","journal-title":"Br J Haematol"},{"key":"8895_CR46","doi-asserted-by":"publisher","first-page":"121883","DOI":"10.1016\/j.jns.2023.121883","volume":"455","author":"SWB Fam","year":"2023","unstructured":"Fam SWB, Pandya S, Parks B, Mashhoon Y, Allen K, Frick G, Beasley K, Zodiatis A, Chitikireddi V, Zhang H, Sabatella G, Mujeebuddin A. Clinical and real-world pharmacovigilance data of meningococcal infections in eculizumab- or ravulizumab-treated patients. J Neurol Sci. 2023;455:121883.","journal-title":"J Neurol Sci"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-025-08895-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-025-08895-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-025-08895-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,6]],"date-time":"2025-09-06T16:28:40Z","timestamp":1757176120000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-025-08895-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,30]]},"references-count":46,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["8895"],"URL":"https:\/\/doi.org\/10.1186\/s13063-025-08895-7","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,30]]},"assertion":[{"value":"23 August 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 May 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 May 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 July 2025","order":4,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Update","order":5,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The licence type has been changed from CC BY-NC-ND to CC BY.","order":6,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"It is the responsibility of the investigator or qualified designee to obtain signed and dated informed consent for each participant prior to conducting any study-related procedures, following an explanation of the nature of the study\u2014including potential benefits and risks.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Participants will be informed about how their personal study-related data will be disclosed and will be required to agree to the information contained in the informed consent and provide consent to the processing of their personal data, if required by applicable data protection law. The level of disclosure must also be explained to the participant who will be required to give consent for their data to be used as described in the informed consent.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"MO reports no competing interests. DCC has acted as a consultant for Alexion, AstraZeneca Rare Disease, Wyngaarten Law, and Fitch Law; received travel support from Edwards Lifesciences; and has stock\/stock options in Lilly and Edwards. KD\u00a0has received research funds from NIPRO CORPORATION. AL\u00a0has consulting agreements with Abbott, Chugai, Renibus Therapeutics, and Alexion AstraZeneca Rare Disease. JLK has received research funds from NIH, Astute-Biomerieux, and Fresenius Medical; and received consulting fees or sat on an advisory board for Alexion, AstraZeneca Rare Disease, Astute-Biomerieux, Baxter, Guard Therapeutics, Novartis, and SeaStar Medical. GL and CMS are employees of Alexion, AstraZeneca Rare Disease. WS and PDW were employees of Alexion, AstraZeneca Rare Disease upon commencing authorship of this manuscript. RLM has consulting agreements with Baxter, AM Pharma, Biomerieux, Mallinckrodt, GE Healthcare, Sanofi, Abiomed, NovaBiomed, Renasym, RenibusTherapeutics, Alexion, AstraZeneca Rare Disease; and has sat on a data and safety monitoring board for Novartis and Guard. PTM is to provide any competing interests. ADS has sat on an advisory board for Alexion AstraZeneca Rare Disease, Novartis, Chugai, RenalGuard, Calcimedica, Retia, AM Pharma, and Fresenius. AZ received consulting fees and grants from DFG, Baxter, Fresenius, Alexion, Bayer, Novartis, AM Pharma, Renibus, Guard Therapeutics, Paion, and Viatris. DTE has sat on advisory boards for Edwards Lifesciences, Astellas Pharma Inc., Medela, and Arthrex Inc. and acted as a consultant for Alexion AstraZeneca Rare Disease, and Renibus Therapeutics.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"181"}}